Statistical Methods for the Assessment of Safety and Efficacy in HIV Clinical Trials

Evaluation of different treatments for HIV should take into account the relative balance of safety and efficacy for each treatment. Often time in HIV clinical trials the primary efficacy outcome measure is time to virologic failure, analyzed in an intention-to-treat manner ignoring the changes from the randomized regimens which occur in a reasonable proportion of study participants, often due to treatment limiting adverse events. Clinically, there is therefore considerable interest in also comparing regimens with respect to the competing outcomes of virologic failure and treatment-limiting adverse events leading to discontinuation of the initial randomized regimen.